BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    PMA: P110022 · Supplement: S008 · Decision Dec 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27

    Basic Information

    Device Name
    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
    Trade Name
    ELECSYS ANTI-HBC IGM TEST SYSTEM
    PMA Number
    P110022
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    LOM
    Generic Name
    Test, hepatitis b (b core, be antigen, be antibody, b core igm)
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 20, 2013
    Date Received
    August 31, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MIGRATION OF CLAIMS FROM THE FDA APPROVED ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM ON THE COBAS E 601 TO THE COBAS E 602 IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM AND IS INDICATED FOR:ELECSYS ANTI-HBC LGM IMMUNOASSAYTHE ELECSYS ANTI-HBC LGM IMMUNOASSAY IS INTENDED FOR THE IN VITRO QUALITATIVEDETERMINATION OFIGM ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, SODIUM HEPARIN, SODIUM CITRATE) IN ADULT PATIENTS WITH SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B (HBV) INFECTION. THE PRESENCE OF ANTI-HBC IGM, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICALINFORMATION, IS INDICATIVE OF ACUTE OR RECENT HEPATITIS B VIRUS (HBV) INFECTION. THE ELECSYS ANTI-HBC LGM IMMUNOASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY.THE ELECTROCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE COBAS E 601 AND COBAS E 602 IMMUNOASSAY ANALYZERS. ELECSYS PRECICONTROL ANTI-HBC ELECSYS PRECICONTROL ANTI-HBC IGM IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HBC IGM IMMUNOASSAY ON THE COBAS E 601 ANDCOBAS E 602 IMMUNOASSAY ANALYZERS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOM Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)